IBS 皮膚パッチテスト 食物アレルギー研究
過敏性腸症候群に対するパッチテストに基づくタイプ 4 食物アレルゲンの食事回避に関する無作為化、二重盲検、プラセボ対照、多施設共同研究
Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the "true" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the "sham" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own.
調査の概要
詳細な説明
See above. When all 250 study participants have finished all parts of the study, the results will be made known to the doctor-investigators for data analysis.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michael B Stierstorfer, MD
- 電話番号：215-699-1929
- メール：mbstierstorfer@gmail.com
研究連絡先のバックアップ
- 名前：Sally Iles, BSN, MBA
- 電話番号：617-922-1130
- メール：sallyiles3@gmail.com
研究場所
-
-
Pennsylvania
-
North Wales、Pennsylvania、アメリカ、19454
- 募集
- North Wales Dermatology, PLLC
-
コンタクト：
- Michael B Stierstorfer, MD
- 電話番号：215-699-1929
- メール：mbstierstorfer@gmail.com
-
コンタクト：
- Sally Iles, BSN, MBA
- 電話番号：617-922-1130
- メール：SallyIles3@gmail.com
-
主任研究者：
- Michael B Stierstorfer, MD
-
Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- University of Pennsylvania Dermatology
-
コンタクト：
- Anna Kersh, MD, PhD
- 電話番号：215-699-1929
- メール：admin@ibsfoodstudy.com
-
コンタクト：
- Sally Iles, BA, MBA
- 電話番号：617-922-1130
- メール：admin@ibsfoodstudy.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or
- meeting the Rome IV IBS diagnostic criteria by history and having suboptimally or poorly controlled IBS symptoms.
Exclusion Criteria:
- Under age 18 years
- Pregnant
- Severe rash
- Receiving any cortisone-containing or any of the following immunosuppressive medications within two weeks prior to patch testing or plan to do so any time during the study: cyclosporine, mycophenylate mofetil, azathioprine, tacrolimus or others within these classes of medications)
- Incapable of completing all parts of the 18-week screening period and study, including following the dietary instructions and completing all text or email questionnaires
- Exposure of back to the sun in the 2 weeks prior to patch testing Unable or unwilling to discontinue the low FODMAP diet, if relevant, starting 1 week prior to the study and for the study duration
8) Refusal to shave back hair, if relevant 9) Receiving pharmacologic therapy for IBS that has been started or changed within 30 days of study enrollment 10) Non-English speaking 11) Unable to provide written informed consent 12) Have a history of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease, or diverticulitis, active within the prior 2 years. 13) Have a history of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal >6 months ago) 14) Have poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia 15) Have excessive alcohol intake (more than 1 drink per day for females and 2 drinks per day for males) 16) Use illicit substances 17) Use high-dose opiates 18) Severe allergy to adhesive tape
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：True avoidance diet
Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic |
Food patch test-directed avoidance diet for 16 weeks where participant avoids avoid eating the food(s) to which they are allergic |
|
偽コンパレータ：Sham avoidance diet
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy |
Avoidance diet for 16 weeks of randomly selected foods to which the patch testing did not show an allergy |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Post-Avoidance Diet Relative IBS Symptom Global Assessment
時間枠：Questionnaire to be completed promptly after completion of 16 week avoidance diet.
|
Participant global assessment of IBS symptoms compared to the three months prior to entering study, assessed by a post-avoidance diet questionnaire. The assessment is a 7 point Likert scale with 1=substantially improved; 2=moderately improved; 3=slightly improved; 4=no change; 5=slightly worse; 6=moderately worse; 7=substantially worse |
Questionnaire to be completed promptly after completion of 16 week avoidance diet.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Michael B Stierstorfer, MD、North Wales Dermatology, PLLC
出版物と役立つリンク
一般刊行物
- Shin GH, Smith MS, Toro B, et al. Utility of food patch testing in the evaluation and management of irritable bowel syndrome. Skin. 2018;2:1-15.
- Stierstorfer MB, Toro B. Patch Test-Directed Dietary Avoidance in the Management of Irritable Bowel Syndrome. Cutis. 2021 Aug;108(2):91-95. doi: 10.12788/cutis.0321.
- Stierstorfer MB, Sha CT, Sasson M. Food patch testing for irritable bowel syndrome. J Am Acad Dermatol. 2013 Mar;68(3):377-84. doi: 10.1016/j.jaad.2012.09.010. Epub 2012 Oct 24.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 1003A
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。